NCT01938638

Brief Summary

The purpose of this study Part A is to determine the safety, tolerability and the pharmacokinetics of BAY1143572 in subjects with advanced malignancies, which are either refractory to or ineligible for treatment with standard agents. The purpose of this study Part B is: Determine the safety, tolerability, pharmacokinetics (PK) and maximum tolerated dose (MTDG-CSF) of BAY1143572 with concurrent administration of the granulocyte colony-stimulating factors (G-CSF) in an intermittent and continuous dosing schedule in subjects with advanced malignancies.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2013

Typical duration for phase_1

Geographic Reach
4 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

September 26, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2016

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

2.9 years

First QC Date

September 5, 2013

Last Update Submit

October 19, 2017

Conditions

Neoplasms

Keywords

Advanced malignanciesTNBCDLBCLGastric cancer

Outcome Measures

Primary Outcomes (2)

  • Number of participants with adverse events as a measure of safety and tolerability

    Up to 2 years

  • Maximum tolerated dose (MTD) of BAY1143572

    In Part A: Maximum tolerated dose (MTD) of BAY1143572 In Part B; Maximum tolerated dose ( MTD) with G-CSF of BAY114357 The MTD is defined as the highest dose that can be given such that not more than 20% of subjects experience a dose limiting toxicity (DLT) during cycle 1.

    Up to 1 year

Secondary Outcomes (6)

  • Maximum total drug concentration (Cmax)

    Cycle 1, Day 1 and Day 15 (each cycle is 28 days)

  • Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)

    Cycle 1, Day 1 and Day 15 (each cycle is 28 days)

  • Area under the plasma concentration-time curve from time zero to infinity (AUC)

    Cycle 1, Day 1 and Day 15 (each cycle is 28 days)

  • Time of maximum observed concentration (tmax)

    Cycle 1, Day 1 and Day 15 (each cycle is 28 days)

  • Tumor response based on RECIST 1.1 or Cheson 2007 criteria

    Up to 100 weeks

  • +1 more secondary outcomes

Study Arms (2)

BAY1143572 [continuous]

EXPERIMENTAL

BAY1143572 will be administered from cycle 1, day 1 (C1D1) onwards once daily continuously

Drug: BAY1143572

BAY1143572 [on/off]

EXPERIMENTAL

BAY1143572 will be administered from C1D1 in a 3 days on/4 days off schedule

Drug: BAY1143572

Interventions

BAY1143572DRUG
BAY1143572 [continuous]BAY1143572 [on/off]

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects aged \>/=21 years
  • Dose escalation phase: Subjects with histologically or cytologically confirmed advanced malignancies (solid tumors and malignant lymphomas) who were refractory to or had exhausted all available therapies. Subjects had to have evaluable or measurable disease (as per RECIST 1.1 or Cheson 2007 criteria).
  • Expansion phase only: Subjects with advanced, histologically or cytologically confirmed gastric cancer, triple negative breast cancer (TNBC), or diffuse large B-cell lymphoma (DLBCL), who were refractory to or had exhausted all available therapies. Subjects had to have evaluable or measurable disease (as per RECIST 1.1 or Cheson 2007 criteria).
  • Archival tumor tissue to conduct molecular and / or genetic studies must be collected from all study subjects enrolled in this study.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Life expectancy of at least 12 weeks
  • Adequate bone marrow, liver, and renal functions as assessed by laboratory analysis to be conducted within 7 days prior to the first dose of study drug
  • International normalized ratio (INR) and partial thromboplastin time (PTT) \</=1.5 times ULN (upper limit of normal)

You may not qualify if:

  • Known hypersensitivity to the study drug or excipients of the preparation or any agent given in association with this study
  • History of cardiac disease including congestive heart failure \> New York Heart Association (NYHA) Class II, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months) or myocardial infarction within the past 6 months and cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin; evidence for uncontrolled coronary artery disease (e.g. angina pectoris, myocardial infarction within 6 months prior to study entry, major regional wall motion abnormalities upon baseline echocardiography)
  • Previous pulmonary embolism within 12 months prior to study entry
  • Uncontrolled hypertension defined as systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg on 2 or more consecutive blood pressure readings, despite optimal medical management
  • Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C
  • Known history of human immunodeficiency virus (HIV) infection
  • Chronic or active hepatitis B or C, requiring antiviral therapy
  • Active clinically serious infections of \> Grade 2 and/or active infections that require treatment with systemic agent
  • Uncontrolled seizure disorder requiring therapy (such as steroids or anti-epileptics with significant CYP interaction)
  • Evidence or history of bleeding disorder, i.e. any hemorrhage / bleeding event of \> Grade 2 within 4 weeks prior to the first dose of study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Fayetteville, Arkansas, 72703, United States

Location

Unknown Facility

Boston, Massachusetts, 02215, United States

Location

Unknown Facility

Ann Arbor, Michigan, 48109, United States

Location

Unknown Facility

Hackensack, New Jersey, 07601, United States

Location

Unknown Facility

New York, New York, 10032, United States

Location

Unknown Facility

Charleston, South Carolina, 29425, United States

Location

Unknown Facility

Singapore, 119228, Singapore

Location

Unknown Facility

Singapore, 169610, Singapore

Location

Unknown Facility

Seoul, 05505, South Korea

Location

Unknown Facility

Seoul, 110-744, South Korea

Location

Unknown Facility

Seoul, 120-752, South Korea

Location

Unknown Facility

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

NeoplasmsStomach Neoplasms

Interventions

atuveciclib

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2013

First Posted

September 10, 2013

Study Start

September 26, 2013

Primary Completion

August 17, 2016

Study Completion

September 19, 2016

Last Updated

October 20, 2017

Record last verified: 2017-10

Locations

SG(2)US(6)KR(3)TW(1)